MAUDE Adverse Event Report: COOK INC FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH; DYB INTRODUCER, CATHETER

Model Number	G56230
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products: st.Jude amplatzer plug abp2 8 mm; unknown amplatz wire; unknown j wire; heparin.(b)(6).Occupation = cath lab tech.Pma/510(k) number = pre-amendment.No code available (3191) for adverse event/ intervention.The patient was taken to surgery for removal of the device.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during an embolization procedure of the right innominate vein collaterals involving a pediatric patient with a history of open heart surgeries and cardiac catheterizations for congenital heart defects, a flexor high-flex ansel guiding sheath separated in the patient.Access was obtained in the right jugular vein and the sheath was placed in the desired location, through anatomy reported to be "a tight turn".Resistance was encountered upon advancement of another manufacturer's embolization device/plug through the complaint device as it approached the distal tip of the sheath.The embolization device would not exit the sheath and was therefore unable to be deployed.The embolization plug was removed, and an unknown j wire was inserted.The j wire reportedly exited the sheath, before the distal tip, and went into the inferior vena cava.The user attempted to remove the sheath over the wire; however, when they pulled on the device, the distal 1/4 separated in the patient.The sheath had reportedly been in place for less than 30 minutes.The dilator was not in place at the time of separation, as it reportedly would not go back in the sheath "due to where it broke".The patient was then sent to surgery for removal of the separated portion of the device.Vessel spasms were not reported.A section of the device did not remain inside the patient¿s body.The patient will return for another attempt to embolize the collateral vessel.The patient is reportedly doing well and has had no adverse effects from this event.Per the user facility, the device will not be released from risk management to the manufacturer for 2 years and 90 days.
Additional Manufacturer Narrative
Investigation/evaluation.Reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control procedures, and specifications of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, specifications, drawings, and quality control procedures were conducted, and no gaps were discovered.Based on the information provided and no product returned, investigation has concluded that this event could not be traced to the device, but to the patient¿s anatomy and unintended user error.Reportedly, the patient¿s anatomy was tortuous and was ¿a tight turn¿; additionally, the dilator was not reinserted prior to removal as per the ifu.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
This mdr is being submitted as having information not previously reported.Additional complaint investigation and record remediation was not performed.Blank fields on this form indicate the information is unknown or unavailable.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9208905
• Report Number: 1820334-2019-02646
• Device Sequence Number: 447616
• Product Code: DYB
• UDI-Device Identifier: 00827002562301
• UDI-Public: (01)00827002562301(17)220611(10)9803068
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G56230
• Device Catalogue Number: KCFW-5.0-35-55-RB-HFANL0-HC
• Device Lot Number: 9803068
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 11/08/2019; 03/23/2020
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 11/11/2019; 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 4 YR